A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation

Abstract

Evaluation of short- and long-term clinical feasibility and exploration of limitations and advantages of a new automatic speaking valve (ASV) for laryngectomized patients with integrated HME, the Provox FreeHands FlexiVoice (FlexiVoice). This ASV not only enables automatic, but also manual closure of the valve. A multicenter, prospective clinical study in 40 laryngectomized patients was conducted. Participants were asked to use the FlexiVoice for 26 weeks. The primary outcome measure was long-term compliance. Secondary outcome measures were: patient preference, hours of FlexiVoice use, device life of adhesive, voice and speech quality, and quality of life. After 26 weeks, 15 patients (37.5 %) were using the FlexiVoice on a daily basis, for a mean of 12.64 h/day (SD ± 5.03). Ten patients (25 %) were using the device on a non-daily basis, for a mean of 3.76 h/day (SD ± 2.07). The remaining 15 patients (37.5 %) discontinued using the FlexiVoice. Sixty percent of the 25 long-term users applied both automatic and manual closure of the valve. Unpredictable fixation of the adhesive was the main reason for discontinuing or not using the FlexiVoice on a daily basis. Overall, 18 patients (45 %) preferred the FlexiVoice, 16 patients (40 %) their usual HME, 3 patients (7.5 %) their usual ASV, 1 patient (2.5 %) preferred no device at all, and in 2 patients preference was not recorded. The minor technical issues identified could be corrected. The Provox FreeHands FlexiVoice appears to be a useful ASV, which allows for hands-free speech in a larger proportion of laryngectomized patients in the present cohort. The additional manual closure option of the device is beneficial for maintaining the adhesive seal longer.

Improving Hands‐Free Speech Rehabilitation in Laryngectomized Patients with a Moldable Adhesive

“…Therefore, this study design as well as the phrasing of the questionnaire could have biased the participants to respond more positively to the questions regarding the new moldable adhesive. An objective or subjective voice assessment as performed in previous clinical trials regarding medical devices to aid hands-free speech, 16,18,19,28 was also not included in the scope of our study. For further studies on this new fixation device, we recommend including objective and subjective voice assessments and visual analog scales with neutral questions to let participants rate product performance in studies regarding the use of ASVs and fixation methods.…”

“…The use of an ASV, therefore, frees up the patient's hands, enabling immediate verbal reaction and reducing the emphasis on the patient's disability, because the patient does not point with his finger to his stoma 15–17 . Despite the clear benefits, regular ASV use is currently achieved by only 20% of laryngectomized patients, mainly due to challenges in achieving a durable and airtight ASV fixation 15–20 . Most laryngectomized patients use a peristomal adhesive to secure the ASV in their tracheostoma opening 21,22 .…”

“…[15][16][17] Despite the clear benefits, regular ASV use is currently achieved by only 20% of laryngectomized patients, mainly due to challenges in achieving a durable and airtight ASV fixation. [15][16][17][18][19][20] Most laryngectomized patients use a peristomal adhesive to secure the ASV in their tracheostoma opening. 21,22 The high phonation pressures that are exerted on the adhesive during hands-free speech, as well as skin irritation, mucus formation, and perspiration, cause the adhesives to detach prematurely.…”

Improving Hands-Free Speech Rehabilitation in Laryngectomized Patients: Preliminary Results of a Novel Intratracheal Fixation Device

“…However, the current use of hands-free speech is limited to only 7-37.5% of laryngectomized patients [2][3][4][5], mainly due to problems with achieving effective ASV fixation in or around the tracheostoma opening. As a fixation method for the HME and ASV, the laryngectomized patients can use either a peristomal adhesive (around the tracheostoma, Figure 1A), or alternatively, an intratracheal cannula or button (inside the tracheostoma).…”

Improving Hands‐free Speech Rehabilitation in Patients With a Laryngectomy: Proof‐of‐Concept of an Intratracheal Fixation Device

“…1,2 The ASV enables patients with a laryngectomy to speak without using manual occlusion, therefore reducing the emphasis on the patient's disability and improving hygiene and dexterity. However, regular use of hands-free speech with an ASV is limited to only 7% to 37.5% of patients, [2][3][4][5][6][7] mainly due to problems with achieving airtight ASV fixation in the tracheostoma opening. [2][3][4][5]8,9 We have developed an intratracheal fixation device (ITFD) as a potential alternative method to improve ASV fixation and ultimately compliance.…”